NCT04346472

Brief Summary

Retrospective longitudinal follow-up in patients with diffuse low-grade glioma with multimodal MRI assessment

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 15, 2020

Completed
Last Updated

April 16, 2020

Status Verified

April 1, 2020

Enrollment Period

3.8 years

First QC Date

April 10, 2020

Last Update Submit

April 15, 2020

Conditions

Low-grade Glioma

Keywords

GliomaMagnetic Resonance ImagingMagnetic Resonance AngiographyDisease ProgressionSupratentorial NeoplasmsBlood VolumeContrast MediaGadolinium DTPAImage Processing, Computer-AssistedNeovascularization, PathologicDiffuse low grade gliomaRelative regional cerebral blood volume ( rRCBV)Early prognosis of anaplasic transformationDiffuse low grade glioma anaplasic transformation

Outcome Measures

Primary Outcomes (1)

  • Longitudinal variation of the relative regional cerebral blood volume

    Longitudinal variation of the relative regional cerebral blood volume from first pass perfusion imaging data for each MRI performed

    1 day

Secondary Outcomes (3)

  • Collection of histological

    1 day

  • Collection of radiological

    1 day

  • Collection of clinical varaibles

    1 day

Study Arms (1)

Gliomes de grade II initial

Gliomes de grade II initial

Other: Repeated Measurements of the relative regional cerebral blood volume

Interventions

Repeated Measurements of the relative regional cerebral blood volumeOTHER

Repeated Measurements of the relative regional cerebral blood volume variation through an every 6 monts Magnetic Resonance Imaging use.

Gliomes de grade II initial

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with diffuse low-grade glioma (WHO grade II)

You may qualify if:

  • Initial WHO grade II
  • At least 3 exploitable MRI each including a morphologic FLAIR sequence and perfusion imaging

You may not qualify if:

  • Major protected person ( trusteeship, curatorship, justice safeguard)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

GliomaDisease ProgressionSupratentorial NeoplasmsNeovascularization, Pathologic

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBrain NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetaplasia

Study Officials

  • Nicolas MENJOT DE CHAMPFLEUR, MD, PhD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2020

First Posted

April 15, 2020

Study Start

March 1, 2016

Primary Completion

December 30, 2019

Study Completion

January 30, 2020

Last Updated

April 16, 2020

Record last verified: 2020-04

Locations

FR(1)